Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
fluticasone propionate/salmeterol · 1 trial · 1 indication
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from the period baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment, period, sequence and center with period baseline as a covariate and patient nested within sequence as a random effect.
| Arm | Type | Description |
|---|---|---|
| Ind/M - FP/Salm - Pbo | EXPERIMENTAL | In Treatment Period 1 (Days 1 \& 2) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning. In Treatment Period 2 (Days 8 \& 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning. In Treatment Period 3 (Days 15 \& 16) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning. Each treatment period was separated by a 6-day washout period. |
| FP/Salm - Pbo - Ind/M | EXPERIMENTAL | In Treatment Period 1 (Days 1 \& 2) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning. In Treatment Period 2 (Days 8 \& 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning. In Treatment Period 3 (Days 15 \& 16) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning. Each treatment period was separated by a 6-day washout period. |
| Pbo - Ind/M - FP/Salm | EXPERIMENTAL | In Treatment Period 1 (Days 1 \& 2) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning. In Treatment Period 2 (Days 8 \& 9) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning. In Treatment Period 3 (Days 15 \& 16) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning. Each treatment period was separated by a 6-day washout period. |
| Name | Type | Description |
|---|---|---|
| fluticasone propionate/salmeterol | DRUG | Fluticasone propionate/salmeterol 250/50 μg twice daily delivered via MDDPI. |
| indacaterol maleate / mometasone furoate | DRUG | Indacaterol maleate / mometasone furoate 500/400 μg once daily delivered via the TWISTHALER device. |
| placebo to indacaterol/mometasone | DRUG | Placebo to indacaterol maleate/mometasone furoate delivered via the TWISTHALER device. |
| placebo to fluticasone propionate/salmeterol | DRUG | Placebo to fluticasone propionate / salmeterol delivered via MDDPI. |
Inclusion Criteria: * Male and female adult patients aged 18-75 years (inclusive), who have signed an Informed Consent Form prior to initiation of any study-related procedure, * Patients with persistent asthma, diagnosed according to Global Initiative for Asthma (GINA) guidelines (National Institut...
Fluticasone propionate/salmeterol is a combination therapy used for the treatment of asthma. It is being developed by Novartis AG and is currently in Phase 2 clinical development. The drug is a small molecule and is intended for patients with persistent asthma.
Fluticasone propionate/salmeterol is being developed by Novartis AG, a company traded under the ticker NVS. The drug is currently in Phase 2 clinical development for the treatment of asthma.
Fluticasone propionate/salmeterol is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. It is being studied for the treatment of asthma.
Fluticasone propionate/salmeterol has one completed clinical trial, NCT00557440, which investigated the 24-hour forced expiratory flow in 1 second (FEV1) profile of a single dose of the drug in adult patients with persistent asthma. The trial enrolled 37 participants in Belgium and Germany.
Fluticasone propionate/salmeterol is not the same as indacaterol/mometasone. The clinical trial NCT00557440 investigated a single dose of indacaterol/mometasone delivered via the TWISTHALER device, not fluticasone propionate/salmeterol. The two are distinct drug combinations.